Saturday, September 22, 2012

#Cinderblocks Device and Diagnostics safety discussion

Tobias Gilk (@TobiasGilk) giving a presentaiton on MRI Safety at the Partnership with Patients Summit at Cerner.

As an Architect they figure out what they don't need to know.

MRI may not have the same issues as radiation-based diagnostics but it still has it's own issues.

Radiology regulations are based on the use of ionizing radiation - which doesn't cover MRI.

We believe MRI is safer because there is no regulation around it's use.  This is not true.

MRI accidents are skyrocketing. Since 2000 there has been more than 500% increase in MRI Accidents by 2009 (523%) while usage grew by 90%.

In the second part of this session Joleen Chambers talks about implantable devices telling the story of her brother's failed elbow implant..

The IOM has found that the FDA's 510(K) medical device approval process is flawed.

We are seeing fewer medical devices introduced each year. However fewer devices are being tested.

Q2 2012 saw over 123 Million medical devices recalled. A New High.

Most recalled medical devices (in the last 5 years) had been released through the FDA's 510(k) process.

Organizations, like the Mayo clinic, maintain registries of devices that are implanted. The information is proprietary and not accessible to the patient. 

When we see Product Warranties for Implantable devices.

We also want Product registries that are accessible to patients.

There is no synchronization between implanted device makers and MRI scanner manufacturers. You can't check if it is safe to scan a patient with an implantable device.

Two different parts of the FDA manage these two areas. They don't interact.

Does the FDA even "know how" to regulate these devices? It is an escalating challenge as devices get more complicated. Is an FDA seal of approval giving a false sense of security.

The MRI is fundamentally safe and yields an incredible amount of information in comparison to the risk. The issue is how the tests are conducted.